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Table 5 Study data collection sources, information collected, and timing of collection for all CombinADO study participants

From: The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial

Measurement

Information collected

Participants

Time

Survey questionnaire

o Basic demographic information, education, and vocation information

o HIV, STI, ART, reproductive health beliefs and literacy

o Adherence and adherence self-efficacy

o Youth readiness for independent health care

o Relationship/marital status

o Mental health

o Life events

o Substance use

o Sexual risk

o Reproductive health, including pregnancy and parenthood

o Interpersonal violence

o Partner, family, and social support

o HIV stigma/disclosure

o Experience with COVID-19

o Uptake of CombinADO strategy intervention components

o Feasibility, acceptability, and appropriateness of all strategy intervention components

AYAHIV

T3

Exit interviews

o Experiences and satisfaction with the services received and various intervention components

AYAHIV

T2

Semi-structured interviews

o Perceived benefits and challenges of attending the support groups

o Comfort taking part in the support group

o Satisfaction with current support groups structure

o Recommendations for refining the existing support groups

Caregivers

T2

o Experience implementing the intervention, including time spent providing care to AYAHIV

o Impact of the intervention on facility and delivery of health services

o Met and unmet needs of the AYAHIV population seeking services

o Adoption, implementation, maintenance, reach, feasibility, acceptability appropriateness, and fidelity of the intervention various components

HCWs and KIs

T1–T3

Costing questionnaire

o The daily schedule at the health facility

o Time spent working across various clinic activities, including consultations with AYAHIV

HCWs

T1 and T2

Blood sampling

o Blood for real-time viral testing

o Dried blood spot (DBS) samples for TDF-DP drug-level testing

AYAHIV

T3

Abstraction of AYAHIV routine data

o Date of HIV diagnosis

o ART start date

o Current ART regimen

o Intercurrent hospitalizations

o Most recent HIV RNA viral load and CD4 results

o Pharmacy dispensing and refill information

o Most recent visit date

o Retention in care

Clinic records

T3

Monitoring of implementation process

o Number and duration of support groups conducted

o Number of AYAHIV and caregivers attending support groups (new/returning)

o Curriculum materials and intervention content delivered

o Number of AYAHIV expected within the clinic and number interacting with various components of the intervention package

o Number of clinic-based peers trained/retained

o Number of support group facilitators trained/retained

o Number of HCWs trained on new service components

o Number of radio and print materials posted/broadcast in the community

Site staff

T2

  1. Time: T1 pre-intervention, T2 intervention implementation, T3 post-intervention implementation